RFA-FD-16-044: PROJECT SUMMARY Collaboration in regulatory systems strengthening and standardization activities to increase access to safe and effective biological products. The project's overall long-term goal is to increase access to quality, safe and effective biological products for the prevention, diagnosis and treatment of priority diseases, especially for use in low- and middle-income countries (LMICs). The project aims to establish the current status of regulatory strengthening in priority LMICs; generate the required international framework for global coordination of regulatory systems strengthening; facilitate and ensure scientific collaboration and enhance regulatory capacities of National Regulatory Authorities and networks to advance global access to safe and effective vaccines and other biologicals; support development of science-based and data-driven norms, standards, guidance and approaches to guide national regulatory authorities; and build a strong relationship with the US Food and Drug Administration for collaborative efforts in regulatory systems strengthening and standardization activities in the area of biological products. In line with the Funding Opportunity Announcement, WHO proposes activities under four objectives: 1) Contribute to the knowledge base of the current state of regulatory oversight of vaccines and biologicals; 2) Provide technical support to regulatory systems; 3) Develop global norms and standards for biological products; and 4) Support regulatory science and other activities to promote the development and increased access to safe and effective biological products. The project will be implemented over 60 months, through 12-months's phases; managed and implemented by a Project Management Team and technical staff in WHO Headquarters, regional and country offices, with ministries of health, national regulatory authorities, national and professional associations, UN agencies and other relevant partners. WHO draws on a wide network of WHO Collaborating Centres, NGOs and 50 National Professional Officers in ministries of health worldwide. Increasing demand for regulatory systems strengthening, increasingly complex global regulatory environments and more players in the global health arena have prompted WHO to elaborate a new operational model for regulatory systems strengthening with a Coalition of partner organisations and the concept of regional Centres of Excellence, on which this project will draw. The new approach is receiving strong political support from global health agencies/partnerships, and collaborative efforts with the US Food and Drug Administration is crucial in this respect.